FDA Medical Device Recalls (openFDA)
Cardinal Health: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
- Recall number
- Z-0346-04
- Recalling firm
- Cardinal Health
- Product
- Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
- Status
- Terminated
- Initiated
- 2003-12-11
- Posted
- 2004-01-14
- Terminated
- 2004-04-08
- Reason
- The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
- Root cause
- Other
- Action
- The firm contacted their consignees on 12/11/2003 by telephone and letter.
- Quantity
- 110 vials
- Distribution
- The product was distributed to customers in OH and PA.
- Lot, serial or model codes
- Lots: #5047293 and #5048892
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 3004293943
- Firm city
- Groveport
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28